Quality and Validation Manager
As the European Quality and Validation Manager you will ensure that our Life Science projects provide a high level of quality that meets our customers’ expectations. You will support Life Science projects during the pursuit and throughout the project to ensure an efficient execution that is in line with requirements and legislation. You will provide leadership to the Validation Engineers working on European projects. To ensure that project execution follows the planned methodology you will perform Internal Quality Audits and report to the Director of Quality Europe.
In This Role, Your Responsibilities Will Be To:
- Provide mentorship on current industry good validation practices, GxP regulations, and upcoming trends in Life Science compliance.
- Participate in the project pursuit phase to fully understand customer validation requirements, resolve appropriate project execution processes, and ensure that validation costs are reflected in the bid.
- Allocate the EU CSV resources to projects.
- Assist the project team in establishing accurate project planning activities.
- Take the responsibility for Validation Lead of specific projects.
- Develop our QMS (PMO) and project execution tools in line with Life Science industry expectations. Encourage the use of tools on projects.
- Support EU Quality Managers with External Audits from Life Science Customers.
- Perform Quality and Life Science training for all relevant functions (Engineers, Project Managers, CSV team).
- Maintain the global CSV support team, and mentor individual CSV engineers in Europe (indirect reports).
Who You Are:
You have the passion to be the ‘Quality Voice’, leading the organization successfully both at a project and organization level. You can listen to a customer’s validation requirements and translate them into an efficient project validation strategy. You have the skills to break down that strategy into vital activities and resources. You are someone who values structured approaches. You can form a team, developing people into experts. You can network, influence, and communicate to achieve results. You are self-motivated.
For This Role, You Will Need:
- Bachelor`s degree or equivalent experience in Engineering or a Technical subject.
- Deep professional understanding of Quality and Computer System Validation within the Life Science sector.
- Strong interpersonal and leadership skills.
- Confirmed experience and personal credibility in front of customers and colleagues.
- Exceptional communication and presentation skills.
- Ability to establish a quality culture within the engineering Life Science team. This means that each member knows what they need to do on a project, and how Emerson procedures expect them to do it.
- Willingness to travel, mostly for short periods e.g. assessments, workshops, and audits at customer sites, as required.
Preferred Qualifications that Set You Apart:
• Technical Understanding of Automation (S88), MES (S95) and industrial software.
• Trained in ISO 9001 with auditor training and shown experience.
• Managerial experience in the areas of Operations and Quality preferred.
• Proficient in English + one additional European language preferred.
• Proven experience in efficiently leading, motivating, and developing teams is ideal.
• Possessing an MBA is highly valued.
• Preferably a member of ISPE.
Our Offer to You
We understand the importance of work-life balance and are dedicated to supporting our employees` personal and professional needs. From competitive benefits plans and comprehensive medical care to equitable opportunities for growth and development we strive to build a workplace that is encouraging and exciting!
Depending on location, our flexible work-from-home policy allows you to make the best of your time, by combining quiet home office days with collaborative experiences in the office so that you can personalize your work-life mix.
Moreover, our global volunteer employee resource groups will empower you to connect with peers who share the same interests, promote diversity and inclusion and positively contribute to communities around us.
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